Indications for TEPADINA:

Superficial papillary carcinoma of the urinary bladder. Intracavitary effusion due to neoplasm of serosal cavities.

Adult:

60mg once weekly for 4 weeks; may repeat up to a total of 3 courses. Retain in bladder for 2hrs. Intracavitary administration: 0.6–0.8mg/kg every 1–4 weeks through same tube used to remove fluid from cavity. Maintenance doses: adjust no sooner than weekly based on blood counts.

Children:

Not established.

Contraindications:

Concomitant live or attenuated vaccines.

Warnings/Precautions:

For thalassemia: do not initiate if stem cell donor unavailable. Increased myelosuppression risk; monitor CBCs periodically and provide supportive care for infections, anemia, thrombocytopenia. Cutaneous toxicity risk with high-dose therapy (see full labeling). Discontinue and treat if anaphylactic or other significant allergic reaction occurs. Monitor serum transminases and bilirubin daily through BMT Day +28 and perform physical exam; provide supportive care if hepatic veno-occlusive disease develops. Do not exceed dose; discontinue if severe CNS toxicity occurs. Elderly. Moderate-to-severe renal or hepatic impairment: monitor for toxicity. Embryo-fetal toxicity. Females of reproductive potential should use highly effective contraception during and for ≥6 months after last dose; and males should use effective contraception during and for ≥12 months after last dose. Pregnancy: verify status prior to initiation. Nursing mothers: not recommended.

Generic Availability:

NO

How Supplied:

Single-dose vial—1

Indications for TEPADINA:

Adenocarcinoma of the breast. Intracavitary effusion due to neoplasm of serosal cavities.

Adult:

Initially 0.3–0.4mg/kg IV given at 1–4 week intervals. Intracavitary administration: 0.6–0.8mg/kg every 1–4 weeks through same tube used to remove fluid from cavity. Maintenance doses: adjust no sooner than weekly based on blood counts.

Children:

Not established.

Contraindications:

Concomitant live or attenuated vaccines.

Warnings/Precautions:

For thalassemia: do not initiate if stem cell donor unavailable. Increased myelosuppression risk; monitor CBCs periodically and provide supportive care for infections, anemia, thrombocytopenia. Cutaneous toxicity risk with high-dose therapy (see full labeling). Discontinue and treat if anaphylactic or other significant allergic reaction occurs. Monitor serum transminases and bilirubin daily through BMT Day +28 and perform physical exam; provide supportive care if hepatic veno-occlusive disease develops. Do not exceed dose; discontinue if severe CNS toxicity occurs. Elderly. Moderate-to-severe renal or hepatic impairment: monitor for toxicity. Embryo-fetal toxicity. Females of reproductive potential should use highly effective contraception during and for ≥6 months after last dose; and males should use effective contraception during and for ≥12 months after last dose. Pregnancy: verify status prior to initiation. Nursing mothers: not recommended.

Generic Availability:

NO

How Supplied:

Single-dose vial—1

Indications for TEPADINA:

Adenocarcinoma of the ovary. Intracavitary effusion due to neoplasm of serosal cavities.

Adult:

Initially 0.3–0.4mg/kg IV given at 1–4 week intervals. Intracavitary administration: 0.6–0.8mg/kg every 1–4 weeks through same tube used to remove fluid from cavity. Maintenance doses: adjust no sooner than weekly based on blood counts.

Children:

Not established.

Contraindications:

Concomitant live or attenuated vaccines.

Warnings/Precautions:

For thalassemia: do not initiate if stem cell donor unavailable. Increased myelosuppression risk; monitor CBCs periodically and provide supportive care for infections, anemia, thrombocytopenia. Cutaneous toxicity risk with high-dose therapy (see full labeling). Discontinue and treat if anaphylactic or other significant allergic reaction occurs. Monitor serum transminases and bilirubin daily through BMT Day +28 and perform physical exam; provide supportive care if hepatic veno-occlusive disease develops. Do not exceed dose; discontinue if severe CNS toxicity occurs. Elderly. Moderate-to-severe renal or hepatic impairment: monitor for toxicity. Embryo-fetal toxicity. Females of reproductive potential should use highly effective contraception during and for ≥6 months after last dose; and males should use effective contraception during and for ≥12 months after last dose. Pregnancy: verify status prior to initiation. Nursing mothers: not recommended.

Generic Availability:

NO

How Supplied:

Single-dose vial—1

Indications for TEPADINA:

To reduce risk of graft rejection when used with high-dose busulfan and cyclophosphamide, as a preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT) for children with class 3 beta-thalassemia.

Adult:

Not applicable.

Children:

Give as IV infusion over 3hrs. 5mg/kg approx. 12hrs apart on Day -6 before allogeneic HSCT in combination with high-dose busulfan and cyclophosphamide. See full labeling.

Contraindications:

Concomitant live or attenuated vaccines.

Warnings/Precautions:

For thalassemia: do not initiate if stem cell donor unavailable. Increased myelosuppression risk; monitor CBCs periodically and provide supportive care for infections, anemia, thrombocytopenia. Cutaneous toxicity risk with high-dose therapy (see full labeling). Discontinue and treat if anaphylactic or other significant allergic reaction occurs. Monitor serum transminases and bilirubin daily through BMT Day +28 and perform physical exam; provide supportive care if hepatic veno-occlusive disease develops. Do not exceed dose; discontinue if severe CNS toxicity occurs. Elderly. Moderate-to-severe renal or hepatic impairment: monitor for toxicity. Embryo-fetal toxicity. Females of reproductive potential should use highly effective contraception during and for ≥6 months after last dose; and males should use effective contraception during and for ≥12 months after last dose. Pregnancy: verify status prior to initiation. Nursing mothers: not recommended.

CancerTherapyAdvisor.com is a free online resource that offers oncology healthcare professionals a comprehensive knowledge base of practical oncology information and clinical tools to assist in making the right decisions for their patients.

Our mission is to provide practice-focused clinical and drug information that is reflective of current and emerging principles of care that will help to inform oncology decisions.